Bay­er wins pri­or­i­ty re­view for CKD pro­gram finerenone af­ter PhI­II da­ta showed a de­lay in dis­ease pro­gres­sion

Less than three months af­ter Bay­er re­leased pos­i­tive Phase III da­ta for a top pro­gram, the FDA has agreed to take up its case.

Reg­u­la­tors have grant­ed pri­or­i­ty re­view for finerenone, an ex­per­i­men­tal drug in pa­tients with chron­ic kid­ney dis­ease and type 2 di­a­betes, Bay­er an­nounced Tues­day. Bay­er did not un­veil an ex­pect­ed PDU­FA date but not­ed the FDA would like­ly give finerenone a typ­i­cal six-month look-over.

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